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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US UNKNOWN HIP ACETABULAR CUP

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DEPUY ORTHOPAEDICS INC US UNKNOWN HIP ACETABULAR CUP Back to Search Results
Catalog Number UNK HIP ACETABULAR CUP
Device Problems Use of Device Problem (1670); Malposition of Device (2616)
Patient Problems Adhesion(s) (1695); Cyst(s) (1800); Foreign Body Reaction (1868); Pain (1994); No Code Available (3191)
Event Date 08/07/2020
Event Type  Injury  
Manufacturer Narrative
(b)(4). If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
 
Event Description
Subject id: (b)(6). Study:dots. Clinical notification received for revision of right hip to address metallosis: date of implantation: (b)(6) 2002, date of revision: (b)(6) 2020 (right hip). Treatment: revision of head and liner products. Update: medical records received on (b)(6) 2020 were reviewed on (b)(6) 2020 by a clinician to identify patient harms/product issues. Doi: (b)(6) 2002: patient received a right pinnacle/srom mom to treat pain and dysfunction secondary to osteoarthritis. Intraoperatively, the surgeon notes there was femoral head arthrosis, mild synovitis, and significant calcification of the labrum. The patient received a pinnacle cup, metal ultamet liner, cocr head, ztt sleeve, and srom stem. The procedure was completed without complications. Clinic note dated (b)(6) 2020: patient presents with right hip pain. Radiology reports reveal that the cup is vertical. The surgeon suspects metallosis and schedules the patient for a revision of the right hip. Dor: (b)(6) 2020: patient received a total revision of the right hip to treat pain secondary to suspected armd. Upon entering the joint, the surgeon identifies and excises scar tissue and a pseudocyst. The cup was well-fixed but vertical, and revised. The stem and sleeve were well-fixed but revised. There was no wear identified on the revised metal liner. The head had some trunnionosis, but no evidence of wear, and was revised. The surgeon notes there was no metallosis in the joint and no pseudotumor present. The patient was revised with depuy products. The procedure was completed without complications. Doi: (b)(6) 2020, dor (b)(6) 2020, right hip.
 
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Brand NameUNKNOWN HIP ACETABULAR CUP
Type of DeviceHIP ACETABULAR CUP
Manufacturer (Section D)
DEPUY ORTHOPAEDICS INC US
700 orthopaedic drive
warsaw IN 46581 0988
Manufacturer (Section G)
DEPUY ORTHOPAEDICS, INC. 1818910
700 orthopaedic dr.
warsaw IN 46581 0988
Manufacturer Contact
kara ditty-bovard
700 orthopaedic dr
warsaw, IN 46581-0988
6107428552
MDR Report Key10548069
MDR Text Key207406331
Report Number1818910-2020-20382
Device Sequence Number1
Product Code KWA
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional,study
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup,Followup
Report Date 09/08/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/17/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue NumberUNK HIP ACETABULAR CUP
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/13/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 09/17/2020 Patient Sequence Number: 1
Treatment
PINN MAR +4 NEUT 36IDX52OD; PINNACLE 100 ACET CUP 52MM; S-ROM M HEAD 36MM +0; SROM SLEEVE; SROM*STM ST,30+4L NK,16X11X150; UNKNOWN HIP ACETABULAR CUP
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